The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days. The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
118
three times daily / 7 days
three times daily / 7 days
6-9mL three times daily / 7 days
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, South Korea
Change of total symptom score from baseline to the end of treatment
Time frame: 7 days
safety assessment
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
Time frame: 7 days
time to response
Time frame: 7 days
compliance, defined by drug accountability
Time frame: 7 days
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three times daily / 7 days